WHO guidelines in quality assessment of herbal drugs

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Shri Tuljabhavani Sewabhawi Shaikshanik Va
Samagik Shikshan Sanstha, Kothari. HI TECH
COLLEGE OF PHARMACY, CHANDRAPUR Padoli Phata
Nagpur Highway, chandrapur-442401 M-Pharmacy
(1st year, 1st Semester) 2021-2022 Department -
Pharmacognosy(MPG) Name - Maroti Madhukar
Jeurkar Roll No - 02 INDUSTRIAL PHARMACOGOSTICAL
TECHONOLOGY Topic - WHO guidelines in quality
assessment of herbal drugs
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• WHO GUIDELINES IN QUALITY ASSESSMENT OF HERBAL
  DRUGS
• Contents
• Introduction
• Objective
• Assessment of
• Quality
• Safety
• Efficacy
• Intended use
• Product information for the consumer
• Utilization of guidelines
• Conclusion

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• WHO GUIDELINES IN QUALITY ASSESSMENT OF HERBAL
  DRUGS
• INTRODUCTION
• Medicinal plants are in use for the purpose of
  treatment of different ailments since centuries.
  There has been an immense increase in sales of
  herbal OTC (Over the counter drugs). This is
  growing to a billion dollar industry.
• The need for safety and efficacy has also
  escalated since the western interest has grown.
  Thus the need for standardization has come into
  view. The process of evaluation of the quality
  and purity of crude drugs by means of various
  parameters like morphological, microscopical,
  physical, chemical and biological observations is
  called standardization. Standardization of the
  herbal drug begins from the collection of the
  herbal drug to its packaging/use as medicine.
• Variability in the chemical composition of the
  soil and changes in the climate influence the
  range of phytoconstituents present in the herbal
  drugs.
• Growing deforestation is leading to increase in
  the number of endangered species of medicinal
  plants. This leads to addition of adulterants or
  substitutes to the herbal drug Addition of
  adulterants and substitutes can change the safety
  and efficacy of the drug.

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• For the purpose of these guidelines herbal
  medicine should be regarded as
• Finished,labelled medicinal products that
  ,contain as active ingredient aerial or
  underground parts of plants, or other plant
  material or combinations there of, whether in the
  crude state or as plant preparations.Plant
  material include juices, gums, fatty oils,
  essential oils and any other substances of this
  nature.Herbal medicines may contain excipients in
  addition to the active ingredients.Medicines
  containing plant material combined with
  chemically defined,isolated constituents of
  plants, are not considered to be herbal medicine.
• Exceptionally, in some countries herbal medicines
  may also contain, by tradition, natural organic
  or inorganic active ingredients which are not of
  plant origin.
• The past decade has seen a significant increase
  in the use of herbal medicines. As a result of
  WHOs promotion of traditional medicines ,
  countries have been seeking the assisstance of
  WHO in identifying safe and effective herbal
  medicines for use in national health care system.
• In both developed and developing countries,
  consumers and health care providers need to be
  supplied with up-to-date and authoritative
  information on the beneficial properties and
  possible harm full effects ,of all herbal
  medicines.

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• Objective
• To define basic criteria for the evaluation of
  quality,safety and efficacy of herbal medicines
  and there by to assist national regulatory
  authorities,scientific organisations and
  manufacturers to under take an assessment of the
  documentation or submission in respect of such
  products.
• As a general rule in this assessment, traditional
  experience means long term use as well as the
  medical, historical and ethonological background
  of those products shall be taken.

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• Assessment of Quality,Safety and Efficacy and
  Intended use
• Pharmaceutical assessment
• This part should cover all important aspects of
  the quality assessment of herbal
  medicines.However,if a pharmacopoeia monograph
  exists it should be sufficient to make reference
  to this monograph. If no such monograph is
  avaliable, a momograph must be supplied and
  should be set out in the same way as in an
  official pharmacopoeia.
• All procedures should be in accordance with Good
  Manufacturing Practices GMP.
• Crude plant material
• The botanical definition,including genus,species
  and authority should be given to ensure correct
  identification of a plant.A definition and
  description of the part of the plant from which
  the medicine is made(egleaf,flower,root) has to
  be provided as well as an indication as to
  whether fresh, dried or traditionally processed
  material is used.The active and characteristics
  constituents should be specified and if,possible,
  content limits should be defined.Foriegn
  matter,impurities and microbial content should be
  defined or limited.vocher specimen,representing
  each lot of plant material processed,should be
  authenticated by a qualified botanist and should
  be store for at least a ten year period.

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• Plant Preparations
• Plant preparation should include powdered plant
  materials, extracts,tintures,fatty or essential
  oils,expressed juices and preparations whose
  production involves a fractionation, purification
  or concentration process.The manufacturing
  process should be described in detail.If any
  other substance is added during the
  manufacture,to adjust the plant preparation to a
  certain level of active or characteristic
  constituents or for any other purpose,the added
  substsnce should be mentioned in the procedure
  description.
• A method for identification, and where possible
  assay of plant preparation should be added.If
  the identification of an active principle is not
  possible,it should be sufficient to identify a
  characteristic substance or mixture of substances
  (egchromatographic fingerprint) to ensure
  consistent quality of preparation

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• Finished products
• The manufacturing procedure and formula including
  the amount of excipients should be described in
  detail.
• A method of identification,and where possible
  quantification,of the plant material in the
  finished product should be defined.
• If the identification of an active principle is
  not possible,it should be sufficient to identify
  a characteristic substsance or mixture of
  substance (eg,chromatographic fingerprinting) to
  ensure consistent quality of the product.
• For important finished produts,confirmation of
  regulatory status in the country of the origin
  should be requiredthe WHO certification scheme
  on the quality of the pharmaceutical products
  moving in International Commerce should be
  applied.

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• Stability
• The physicsal and chemical stability of the
  product in the final marketing container should
  be tested under defined storage conditions and
  the shelf-life should be established.
• Safety assessment
• This part should cover all the relavent aspects
  of the safety assessment of a medicinal product
  has been traditionally used with out demonstrated
  harm no specific restrictive regulatory action
  should be undertaken unless new evidence demands
  a revised risk-benefit assessment.
• Toxicological studies
• If any toxicological studies are available, they
  should be part of the assessment.If a
  toxicological risk is known, toxicity data have
  to be submited.Risk assessment, whether it is
  independent of dose (eg,special danger allergies)
  ,or whether it is a function of dose should be
  documented.

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• Assessment of Efficacy and Intended use
• This part should cover all the important aspects
  of efficacy assessment. A review of the relavent
  literature should be carried out and copies
  provided of the original articles or proper
  references to them.
• Activity
• The pharmocological and clinical effects of the
  active ingredients and,if known,their
  constituents with therapeutic activity shoud be
  specified or described.
• Evidence required to support indications
• The indications for the use of medicine should be
  specified.In the case of traditional
  medicines,the requrements for proof of efficacy
  shall depend on the kind of indication.

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• Combination products
• As many herbal remedies consist of a combination
  of several active ingredients, and as experience
  on the use of traditional remedies is often based
  on he combination of products,the assessment
  should differentiation between old and new
  combinations products. Identical requrements for
  the assessment of old and new combinations would
  result in an appropriate assessment of certain
  traditional medicines.
• In the case of traditionally used combination
  products,the documentation of traditional use and
  experience may serve for documentation of
  efficacy.
• In ordeer to justify the efficacy of a new
  ingredient and its positive effect on the total
  combination,clinical studies may be reqired.

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• Product Information for the Consumer
• The labelling of the products and the package
  insert should be understandable to the
  consumer/patient. The package informstion should
  cover all necessary information on the proper use
  of product. The following elements of
  information usually suffice
• Name of the product
• Quantitave list of active ingredient
• Dosage form
• Indications
• Dosage (if appropriate,specified for children and
  the elderly)
• Mode of administration
• Duration of use
• Major adverse effects,if any
• Over dosage information
• Contraindication,warnings,precautions and major
  drug indications
• Use during pregnancy and lactation
• Expiry date
• Lot number
• Holder of the marketing authorisation

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• Promotion
• Advertisements and other promotional activities
  to health personnel and the lay public should be
  fully consistent with the approved package
  information.
• Utilization of guidelines
• WHO guidelines for the assessment of herbal
  medicines are intended to facilitate the work to
  a carried out by regulatory authority, scientific
  bodies and industry in the development , and
  assessment and registration of such products.
• The effective regulation and control of herbal
  medicines moving in international commerce also
  require close liaison with appropriate national
  institutions that are able to keep under regular
  review all aspects of their production and use ,
  as well as to conduct or sponser evaluative
  studies of their efficacy,toxicity,safety,acceptab
  ility, cost and relative value compared with
  other drugs used in modern medicine.

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